HEAD & NECK CANCERS

A complete response letter from the FDA has been issued regarding the biologics license application for toripalimab with or without chemotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.

For Head and Neck Cancer Awareness Month, Robert L. Ferris, MD, PhD, FACS, elaborated on the significant progress in the head and neck cancer space, as well as potentially practice-changing results that will come with emerging agents In an interview with Targeted Oncology™.

The FDA has granted fast track designation to SQZ-PBMC-HPV for the treatment of patient with HPV16-positive advanced or metastatic solids tumors, according to an announcement by SQZ Biotechnologies.

According to results from the phase 1b portion of the study KEYNOTE-B84 study, pepinemab plus pembrolizumab achieved complete responses in 2 of the first 3 patients with head and neck cancers enrolled.

Updated results from the RATIONALE-309 study show that tislelizumab continues to prolong PFS extend PFS after the next line of therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

Treatment with PT-112 has begun in a phase 2 study of patients with thymoma and thymic carcinoma.

Results from a study evaluating circulating tumor tissue–modified viral (TTMV)–human papillomavirus (HPV) DNA among patients treated for HPV-driven oropharyngeal squamous cell carcinoma is of interest.

Adding toripalimab to the chemotherapy combination of gemcitabine and cisplatin may lead to better efficacy outcomes in patients with advanced nasopharyngeal carcinoma, compared with chemotherapy alone.

Promising early results have been announcement from a phase 2 study of tisotumab vedotin in select patients with squamous cell carcinoma of the head and neck.

In patients with early stage glottic larynx tumor-focused stereotactic radiotherapy showed benefit in a phase 2 study.

Findings from the MC1273 and MC1675 trials show that de-escalated adjuvant radiation therapy met criteria for efficacy in human papillomavirus–related oropharyngeal squamous cell carcinoma.

Regarding cutaneous squamous cell carcinoma, what is most exciting is the remarkable complete response rate, up to almost 50%, according Jiaxin Niu, MD.

New data show that de-escalated radiotherapy dose to 54 Gy vs 70 Gy may achieve better measures of toxicity in patients with p16-positive oropharyngeal squamous cell carcinoma.

Findings from the phase 1/2 IPH2201-203 trial support the statement that monalizumab, cetuximab, and durvalumab show promising activity in patients with recurrent squamous cell carcinoma of the head and neck.

According to Robert L. Ferris, MD, PhD, there is a steady pace of drug development for head and neck cancers despite modest findings with durvalumab triplet.

Dosing of nanatinostat and valganciclovira in a phase1b/2 clinical trial has been initiated.

A phase 2 study is preparing to enroll patients with Epstein-Barr virus-positive advanced nasopharyngeal carcinoma, who will be treated with an investigational EBNA1 inhibitor.

Phase 1b data indicate that pembrolizumab in combination with pepinemab is safe for the frontline treatment of advanced, recurrent, or metastatic head and neck squamous cell carcinoma.

Results from the phase 3 JUPITER-02 trial show that oncologists can extend progression-free survival in patients with nasopharyngeal carcinoma by adding toripalimab to chemotherapy.

In a phase 3 clinical trial, avasopasem appeared to lower the rate of severe oral mucositis in patients.

The novel checkpoint inhibitor, evorpacept induced responses in patients with head and neck squamous cell carcinoma and gastric cancer when used in combination with anticancer therapy and chemotherapy in a phase 1b study.

The biologics license application for toripalimab will undergo a speedy review by the FDA for consideration as a frontline treatment option for patients with advanced recurrent or metastatic nasopharyngeal carcinoma in combination with gemcitabine and cisplatin, and as a single-agent for the second-line or above treatment of recurrent or metastatic disease after platinum-containing chemotherapy.

Joseph M. Curry, MD, discussed the efficacy of durvalumab in combination with metformin for the treatment of squamous cell carcinoma of the head and neck during an interview with Targeted Oncology.

NBTXR3, which is activated by radiotherapy, was found to be safe and tolerable in frail patients with head and neck squamous cell carcinoma. The agent can be used on its own or in combination with other immunotherapy agents.

The primary end point of the ROMAN trial was not reached after avasopasem was found to not significantly reduce the incidence of severe oral mucositis. A full analysis of the results is ongoing.

In an interview with Targeted Oncology, Marshall Posner, MD, discusses the use of the HB-201 and HB-202 vaccines in patients with human papillomavirus 16- positive cancers.

Treatment with larotrectinib in patients with various subtypes of salivary gland tumors led to a high rate early and durable responses.

Responses achieved with immunotherapy preoperatively with could lead to lasting benefit in patients with HOV-associated head and neck squamous cell carcinoma.

The emergence of early-phase immune-oncology agents and their respective novel mechanisms of action in head and neck squamous cell carcinoma suggests a new standard of care in the metastatic first-line setting within the next 2 years.

Preliminary research suggests that lopofosine I-131 in combination with external beam radiation is safe and tolerable in patients with relapsed or refractory head and neck cancer.